KUCHLI ASOS VA KUCHSIZ KISLOTA, KUCHLI KISLOTA VA KUCHSIZ ASOSDAN TASHKIL TOPGAN TUZLARDAN INYEKSION ERITMALAR TAYYORLASH: FIZIK-KIMYOVIY ASOSLAR VA TEXNOLOGIK YONDASHUVLAR
DOI:
https://doi.org/10.5281/zenodo.20610331Keywords:
ionik gidroliz, pH nazorati, inyeksion eritmalar, natriy atsetat, ammoniy xlorid, magniy sulfat, buferlash, sterilizatsiya, ICH Q8(R2), osmolallik.Abstract
Ushbu tadqiqotda kuchli asos va kuchsiz kislota (natriy atsetat, natriy borat, natriy fosfat) hamda kuchli kislota va kuchsiz asosdan (ammoniy xlorid, magniy sulfat, rux sulfat) tashkil topgan tuzlar asosida tayyorlangan inyeksion eritmalarning fizik-kimyoviy xossalari, pH barqarorligi va sterilizatsiya chidamliligi o'rganildi. Ionik gidroliz nazariyasi asosida har bir tuz sinfi uchun pH ni nazorat qilishning matematik modeli ishlab chiqildi va pKa/pKb qiymatlari yordamida maqsadli pH diapazoni ta'minlandi. pH-metriya, titrlash usullari va osmolyallik nazorati qo'llanildi; sterilizatsiya avtoklav (121 °C, 15–20 min) hamda membrana filtratsiyasi (0.22 µm) usullari bilan amalga oshirildi. Natijalar shuni ko'rsatdiki, natriy atsetat (0.9%) eritmasi pH = 8.87 ± 0.03, ammoniy xlorid (1.0%) eritmasi pH = 5.12 ± 0.04 qiymatida barqaror bo'lib, ikkalasi ham Davlat farmakopeyasi (GF-ME) va ICH Q8(R2) talablariga javob berdi. Tiklanish ko'rsatkichi 97.3–99.1% diapazonda, RSD < 2.0% darajasida qayd etildi (n = 6). In vitro gemoliz sinovi (0.3–3.4%) va in vivo toksisite sinovlari (LD₅₀ > 595 mg/kg) inyeksion qo'llash uchun xavfsizlikni tasdiqladi. Olingan natijalar gidrolizlanadigan tuzlardan farmatsevtik sifatli inyeksion eritmalar tayyorlash uchun ratsional texnologik yondashuv asosini yaratadi.References
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